Note: This document contains side effect information about clobazam. Some dosage forms listed on this page may not apply to the brand name Onfi.

Summary

Common side effects of Onfi include: constipation, drowsiness, fever, sedated state, aggressive behavior, ataxia, lethargy, drooling, and irritability. Other side effects include: pneumonia, urinary tract infection, cough, bronchitis, dysarthria, dysphagia, fatigue, insomnia, decreased appetite, and increased appetite. Continue reading for a comprehensive list of adverse effects.

Applies to clobazam: oral film, oral suspension, oral tablet.

Serious side effects of Onfi

Along with its needed effects, clobazam (the active ingredient contained in Onfi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clobazam:

More common

• Difficulty with swallowing
• fever
• shakiness and unsteady walk
• unsteadiness, trembling, or other problems with muscle control or coordination

Less common

• Change in speech pattern
• restlessness
• slurred speech
• trouble sitting still
• trouble speaking

Incidence not known

• Agitation
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• chest pain
• chills
• confusion as to time, place, or person
• cough
• diarrhea
• difficult or trouble breathing
• holding false beliefs that cannot be changed by fact
• irregular, fast or slow, or shallow breathing
• itching, rash, hives, or welts
• joint or muscle pain
• lack of feeling or emotion
• painful or difficult urination
• pale or blue lips, fingernails, or skin
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• seeing, hearing, or feeling things that are not there
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• unusual bleeding or bruising
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking clobazam:

Symptoms of overdose

• Agitation
• blurred vision
• change or loss of consciousness
• changes in patterns and rhythms of speech
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• loss of strength or energy
• nightmares
• shakiness and unsteady walk
• slurred speech
• sweating
• talkativeness
• trouble speaking
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual excitement, nervousness, restlessness, or irritability

Other side effects of Onfi

Some side effects of clobazam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Aggressive
• body aches or pain
• decreased appetite
• difficulty having a bowel movement
• drooling
• ear congestion
• irritability
• loss of voice
• runny or stuffy nose
• sneezing
• vomiting

Less common

• Bladder pain
• cloudy urine
• cough with mucus
• frequent urge to urinate
• increased appetite
• lower back or side pain

Incidence not known

• Double vision
• full or bloated feeling
• headache
• muscle spasms
• pressure in the stomach
• red skin
• swelling of the stomach area

For Healthcare Professionals

Applies to clobazam: oral film, oral suspension, oral tablet.

General

The most commonly reported side effects included sedation or somnolence, tiredness, pyrexia, and lethargy.^[Ref]

Nervous system

Altered consciousness more commonly occurred in older patients, and may have been combined with respiratory disorders.

Anterograde amnesia occurred in the normal dose range, but was more frequently reported with higher doses.

Articulation disorders, gait disorders, other motor function disorders, slow speech, and/or speech disorder were typically reversible and occurred more frequently with higher doses and/or at the beginning of treatment.

Fine tremor of the fingers typically occurred at the beginning of treatment, and usually disappeared with continued treatment.

Nystagmus occurred more frequently with higher doses and/or with prolonged treatment.

Somnolence occurred more frequently with higher doses and/or at the beginning of treatment.^[Ref]

Very common (10% or more): Sedation or somnolence (up to 32%), somnolence (up to 25%), lethargy (up to 15%), drooling (up to 14%)

Common (1% to 10%): Ataxia, dizziness, disturbance in attention, dysarthria, headache, psychomotor hyperactivity, sedation, slow speech, slurred speech, speech disorder, tremor

Uncommon (0.1% to 1%): Amnesia, anterograde amnesia, memory impairment

Very rare (less than 0.01%): Impaired consciousness

Frequency not reported: Articulation disorders, cognitive disorder, fine tremor of the fingers, gait disorders, indistinct speech, nystagmus, other motor function disorders, slow response to stimuli, unsteady gait/movement^[Ref]

Other

Very common (10% or more): Tiredness (up to 32%), pyrexia (up to 17%)

Common (1% to 10%): Drug tolerance, fatigue

Uncommon (0.1% to 1%): Fall

Frequency not reported: Hangover, hypothermia, paradoxical reaction, reaction time slowed^[Ref]

Psychiatric

Very common (10% or more): Aggression (up to 14%), irritability (up to 11%)

Common (1% to 10%): Confusion/confusional state, depression/unmasked preexisting depression, insomnia, restlessness

Uncommon (0.1% to 1%): Abnormal behavior, anxiety, delusion, loss of libido, nightmare, numbed emotions

Frequency not reported: Abuse, acute agitational states/agitation, anger, decreased libido, dependence/physical dependence/psychic dependence, difficulty falling asleep/staying asleep, euphoria, fits of rage, habituation, hallucinations, inappropriate behavior, initial insomnia, poor quality sleep, psychotic disorder/reactions, rebound phenomena, suicidal ideation, suicidal tendencies, withdrawal

Postmarketing reports: Apathy, delirium^[Ref]

Dependence more commonly occurred during prolonged use.

Loss of libido was typically reversible and occurred more frequently with higher doses and/or with prolonged treatment.

Withdrawal and rebound phenomena have occurred with discontinuation of treatment.^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 14%)

Common (1% to 10%): Bronchitis, cough, pneumonia

Very rare (less than 0.01%): Respiratory disorders

Frequency not reported: Respiratory depression, respiratory failure

Postmarketing reports: Aspiration^[Ref]

Respiratory failure more commonly occurred with high doses and/or in patients with preexisting compromised respiratory function (e.g., bronchial asthma, brain damage).^[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, dry mouth, dysphagia, nausea

Frequency not reported: Vomiting

Postmarketing reports: Abdominal distention, lip edema^[Ref]

Metabolic

Common (1% to 10%): Decreased/increased appetite

Uncommon (0.1% to 1%): Weight increased

Frequency not reported: Anorexia^[Ref]

Dermatologic

Common (1% to 10%): Rash

Very rare (less than 0.01%): Cutaneous reactions, urticaria

Frequency not reported: Photosensitivity reaction, pruritus, Stevens-Johnson syndrome, sweating, toxic epidermal necrolysis (TEN)/fatal TEN

Postmarketing reports: Facial edema^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Postmarketing reports: Urinary retention^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension^[Ref]

Ocular

Uncommon (0.1% to 1%): Diplopia

Frequency not reported: Blurred vision, visual disorders^[Ref]

Diplopia was typically reversible and occurred more frequently with higher doses and/or at the beginning of treatment.^[Ref]

Musculoskeletal

Frequency not reported: Muscle aches, muscle spasms/frequent muscle spasms, muscle weakness, spasm, stiffness^[Ref]

Hematologic

Frequency not reported: Abnormal hematologic tests

Postmarketing reports: Anemia, eosinophilia, leukopenia, thrombocytopenia^[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests

Postmarketing reports: Increased liver enzymes^[Ref]

Hypersensitivity

Postmarketing reports: Angioedema^[Ref]